On September 26, 2011, AMDR submitted comments to FDA’s docket seeking input on the reprocessing of reusable medical devices:

In AMDR’s August 1, 2011 comments, we highlighted that FDA’s experience in regulating the reprocessors of SUDs applies to its current efforts to identify factors affecting the reprocessing of reusable devices.  As we explained, FDA already has in place a long-standing, stringent regulatory framework for reprocessors of SUDs.  The result of FDA’s regulatory requirements for SUD reprocessors is that reprocessed SUDs are as safe and effective as original devices and pose no increased risk to patients.  In addition to the decade of safe clinical use, both FDA and the independent U.S. Government Accountability Office (GAO) have concluded that there is no evidence of harm to patients from FDA-regulated reprocessed SUDs.[1]

AMDR is proud to have worked with FDA to ensure that our reprocessed SUDs are safe and effective for clinicians and patients.  The leadership demonstrated by FDA in choosing to legitimize the third-party SUD reprocessing industry through regulation is now looked at as a model.  AMDR believes that FDA is again poised to demonstrate such leadership with these new activities aimed at encouraging proper reprocessing of reusable devices….

[1]               U.S. Government Accountability Office, GAO-08-147, Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk (January 2008), at 14-19 (“After reviewing the available evidence—including FDA’s process for identifying and investigating device-related adverse events reported to involve reprocessed SUDs, peer-reviewed studies published since 2000, and the results of our and FDA’s consultations with hospital representatives—we found no reason to question FDA’s analysis indicating that no causative link has been established between reported injuries or deaths and reprocessed SUDs. That is, the available information regarding safety, while not providing a rigorous safety comparison between reprocessed SUDs and other devices, does not indicate that reprocessed SUDs currently in use pose an increased safety threat”) (emphasis added).